Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 4/21/2016 |
| Start Date: | September 2002 |
Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes
RATIONALE: Doxercalciferol may improve low blood cell counts and decrease the need for blood
transfusions and may be an effective treatment for myelodysplastic syndrome or chronic
myelomonocytic leukemia.
PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients
who have myelodysplastic syndrome or chronic myelomonocytic leukemia.
transfusions and may be an effective treatment for myelodysplastic syndrome or chronic
myelomonocytic leukemia.
PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients
who have myelodysplastic syndrome or chronic myelomonocytic leukemia.
OBJECTIVES:
- Determine the response rate of patients with myelodysplastic syndromes or chronic
myelomonocytic leukemia treated with doxercalciferol.
- Determine the toxicity profile of this drug in these patients.
- Determine the time to progression and overall survival of patients treated with this
drug.
OUTLINE: Patients receive oral doxercalciferol daily for 12 weeks. Treatment continues in
the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 41 patients will be accrued for this study.
- Determine the response rate of patients with myelodysplastic syndromes or chronic
myelomonocytic leukemia treated with doxercalciferol.
- Determine the toxicity profile of this drug in these patients.
- Determine the time to progression and overall survival of patients treated with this
drug.
OUTLINE: Patients receive oral doxercalciferol daily for 12 weeks. Treatment continues in
the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 41 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Morphologically and cytogenetically confirmed myelodysplastic syndromes or chronic
myelomonocytic leukemia
- No more than 20% blasts by bone marrow biopsy
- Must meet at least 1 of the following criteria:
- Anemia
- Hemoglobin less than 11 g/dL over a 2-month period
- Thrombocytopenia
- Neutropenia
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
Hepatic
- ALT and AST less than 1.5 times upper limit of normal
- Bilirubin less than 3 mg/dL
- Albumin greater than 3.0 g/dL
Renal
- Creatinine clearance greater than 50 mL/min
- No history of hypercalcemia
- No renal stones within the past 5 years
Cardiovascular
- No clinically significant heart failure
- No uncontrolled hypertension
Pulmonary
- No clinically significant pulmonary failure
Other
- Not pregnant
- Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior growth factor or cytokine therapy
Chemotherapy
- At least 8 weeks since prior cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- Concurrent transfusion support allowed
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